(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition that the blue led was flashing and the device failed self-test and the charger was defective was confirmed.It was further noted that the blue led lights up instantly.However, the assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted.
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It was reported by (b)(6) that during service and evaluation of the universal battery charger device, it was observed that the blue led was flashing, the device failed self-test, and was defective.It was noted in the service order that the "universal battery charger lights keeps flashing".This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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